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Cytobrush Plus C0004

by CooperSurgical, Inc.

Part of a family of 7 devices: see the family page

Ref C0004Model 70124-001

Cytobrush Plus C0004 is a cervical cytology brush (EU MDR Class I; FDA Class II; FDA product code HHT, Spatula, Cervical, Cytological) made by CooperSurgical, Inc., registered in EUDAMED on 22 May 2026 (Basic UDI-DI 0888937TD006ns2S), cleared under FDA 510(k) K832986 on 10 Feb 1984 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 50888937003173), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K832986

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888937TD006ns2S Basic UDI-DI 50888937003173UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number50888937003173 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK832986 Date10 Feb 1984DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD006ns2S registered 22 May 2026 Active
  • FDA 510(k) K832986 decided 10 Feb 1984 Active
  • FDA GUDID UDI-DI 50888937003173 listed 21 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K832986
  2. Listed FDA GUDID 50888937003173
  3. Registered EUDAMED 0888937TD006ns2S

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cytobrush® Plus EUDAMED
Cytobrush Plus GUDID
Generic name
Cervical cytology brush
Device name
Medscand® Sample Collection Kit
Model / reference
C0004, 70124-001
Primary DI / UDI-DI
50888937003173
Basic UDI-DI
0888937TD006ns2S
510(k) Number
FDA product code
HHT
EMDN code
W02020502 Cervical screening systems
GMDN term
Cervical cytology brush
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.4530
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cervical cytology brush

Cleared under the same submission (K832986)

and 6 more cleared under K832986

Similar devices in this category

Other devices filed under HISTOLOGY / CYTOLOGY.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)